Rheumatic heart disease. Rheumatic fever with heart involvement
Conditions
Interventions
Intervention 1: Intervention group: CardiaMed mechanical valve - In this group a CardiaMed mechanical valve (CardiaMed
Penza, Russia) will be implemented via an open heart surgery in the mitral valve position. During a general anesthesia, the rheumatic mitral valve will be excised during open surgery and the CardiaMed
Sponsors
Dastavard-e-Sina Co.
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: Candidate for mechanical valve replacement due to rheumatic heart valve disease Isolated mitral valve replacement
Exclusion criteria
Exclusion criteria: Patients undergoing re-do surgeries Patients with left ventricular ejection fraction =35% Concomitant coronary artery bypasses graft surgery Concomitant other valve surgeries Patients suspicious for native valve endocarditis Patients with contraindicated warfarin consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Valvular function. Timepoint: Preoperative, Early postoperative, 6 months postoperative, 1 year postoperative. Method of measurement: Echocardiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding. Timepoint: Postoperative and 1 year after surgery. Method of measurement: Physical examination and checking INR.;Heart valve re-operation. Timepoint: Postoperative and 1 year after surgery. Method of measurement: Physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholamreza Omrani
Iran University of Medical Sciences
Outcome results
None listed